Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System since the 2010 issuance of ICH Q10. Yet these disciplines have remained largely distinct and disconnected in practice. This paper presents a two-part literature review on this topic. First is a review of how other industries have connected risk management and knowledge management. This is followed by a review of relevant biopharmaceutical industry regulatory guidance to explore expectations for how risk, risk management, knowledge and knowledge management are interdependent. The results suggest there is a strong argument in favor of linking risk management and knowledge management and other industries have demonstrated benefits in doing so. Furthermore, the review of the biopharmaceutical industry regulatory guidance shows the clear and persistent benefits of connecting the expectations of managing risk and knowledge together. A key conclusion is that risk varies inversely with knowledge application and therefore, a lower level of risk to quality (and ultimately to the patient) can be achieved through risk management practices when a thoughtful and programmatic approach to knowledge management is in place, providing the best possible knowledge to assess and control risk.



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Creative Commons Attribution-Noncommercial 4.0 License
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